Brian E Louie, C Daniel Smith, Christopher C Smith, Reginald C W Bell, George Kevin Gillian, Jeffrey S Mandel, Kyle A Perry, Walter Kurt Birkenhagen, Paul A Taiganides, Christy M Dunst, Howard M McCollister, John C Lipham, Leena K Khaitan, Shawn T Tsuda, Blair A Jobe, Shanu N Kothari, Jon C Gould
OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA...
August 2019: Annals of Surgery